Suspension of ulipristal acetate for treatment of uterine fibroids during ongoing EMA review of liver injury risk

The Health Products Regulatory Authority writes to inform you that the European Medicines Agency (EMA) has recommended temporary suspension the marketing authorisation of 5-mg ulipristal acetate (Esmya and generic medicines) indicated for treatment of uterine fibroids throughout the European Union while the Pharmacovigilance Risk Assessment Committee (PRAC), EMA's safety committee, reviews the risk of serious liver injury.

This review has been initiated following a recent case of liver injury, which led to liver transplant in a patient taking Esmya 5 mg (ulipristal acetate). An EMA review in 2018 concluded that there is a risk of rare but serious liver injury with ulipristal acetate medicines for the treatment of uterine fibroids, and to minimise the risk measures were implemented including restriction of use and recommendations for regular liver function testing. This new case of serious liver injury occurred in spite of adherence to these measures. The suspension and following temporary measures have been implemented while this review is ongoing.

• Ulipristal acetate 5 mg must not be initiated in any new patients
• Patients currently being treated should stop taking ulipristal acetate for uterine fibroids.
• Contact your patients currently on treatment with ulipristal acetate 5 mg for uterine fibroids as soon as possible, and stop their treatment.
• Advise your patients to immediately report signs and symptoms of liver injury (such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia, jaundice), which could occur after stopping treatment
• Liver function tests should be performed within 2-4 weeks after treatment has stopped.

A direct healthcare professional communication (DHPC) will be sent on or soon after 23 March 2020 to healthcare professionals prescribing or dispensing the medicine informing them on these measures. In addition, further information and updated recommendations will be provided once the review is concluded.

The EMA public health communication on the temporary measures is attached to this email and further information on the review can be found at the link below:

https://www.ema.europa.eu/en/medicines/human/referrals/ulipristal-acetate-5mg-medicinal-products

Ulipristal acetate is also authorised as a 30-mg single-dose medicine for emergency contraception (ellaOne and other trade names). This suspension and safety review does not affect the 30-mg ulipristal acetate emergency contraceptive and there is no concern to date of liver injury with these medicines.